Lexology August 22, 2024
Questel

Navigating the complex regulatory compliance landscape in the life sciences sector is a formidable challenge, especially when dealing with medical devices and pharmaceutical translations. The European Union Medical Device Regulation (EUMDR) and In Vitro Diagnostic Regulation (IVDR) have introduced stringent requirements, making it more crucial than ever for companies to avoid common pitfalls. As the Director of Life Sciences Business Development, I have observed how these regulations impact our industry and the vital role of high-quality translation in achieving compliance.

Here, I’ll share ten tips to help you overcome these challenges and ensure your translations meet regulatory standards.

1. Understand the Regulatory Landscape

Before embarking on any translation project, it’s essential to understand the regulatory requirements of the target market...

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Topics: Biotechnology, Govt Agencies, Pharma / Biotech, Regulations
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